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NCT Number: NCT01460706

Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

The purpose of this study is to characterize tumour uptake of somatostatin analog 68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status of the tumor specimen.

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Key information

Conditions

Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Turku PET Centre, Turku University Hospital

Turku, FI-21100, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 to 70 years old
  • Language spoken: Finnish or Swedish
  • Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
  • Supratentorial malignant glioma based on MRI imaging
  • Supratentorial recurrent glioma based on MRI and/or [11C]methionine PET imaging
  • Patients must be able to understand the meaning of the study and sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff

Exclusion criteria

  • Any medical or psychiatric condition that compromises the subject´s ability to participate in the study
  • Any other significant disease including liver or renal disease
  • Pregnant or lactating women

Treatment and study plan

[68Ga]DOTATOC

Drug

120MBq 68Ga-DOTATOC intravenously and PET/CT imaging. Performed once to a patient before the surgery.

Primary outcomes

  1. Malignant glioma uptake of 68Ga-DOTATOC

    Time frame: within 90 minutes post-injection

    PET/CT imaging of the brain starts immediately after the intravenous bolus injection of 68Ga-DOTATOC. Dynamic PET/CT imaging is done over 60-min. A late 90-min scan will be obtained for selected patients. PET studies are analyzed by determining the Standardized Uptake Values (SUV) of the tumor using regions of interest (ROI) drawn both manually and automatically on the tumor.

Secondary outcomes

  1. Immunohistochemical SST2 receptor status of the tumor specimen

    Time frame: After glioma surgery within 4 weeks of PET/CT imaging

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

PET/CT Imaging of Malignant Glioma With Somatostatin Analog 68Ga-DOTATOC

Acronym: DOTAGLI

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 27, 2011
Registry last updated
Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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